Sorin Biomedica, Fiat, USA, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Sorin Biomedica, Fiat, USA, Inc.” (first 1980, latest 1994), across 16 product codes in 4 review panels. Median 510(k) review time under this name: 116 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under LivaNova, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 | 2 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 2 | 2 |
| DXY | Implantable Pacemaker Pulse-Generator | 2 | 2 |
| KRL | Detector, Bubble, Cardiopulmonary Bypass | 2 | 2 |
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 1 | 1 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 | 1 |
| CIB | Radioimmunoassay, Angiotensin I And Renin | 1 | 1 |
Plus 6 more product codes.
Review panels
Most recent Sorin Biomedica, Fiat, USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931444 | PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS | DTZ | 1994-05-27 | 431 |
| K925661 | STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE | KRL | 1993-05-18 | 189 |
| K925615 | SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE | CBI | 1993-03-26 | 140 |
| K925369 | BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS | DTR | 1993-03-26 | 154 |
| K924354 | STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR | DTW | 1993-02-18 | 190 |
| K925541 | STOCKERT 1/4 BUBBLE SENSOR | KRL | 1993-02-02 | 91 |
| K922933 | SORIN MONOLYRH INTEGRATED MEMBRANE LUNG | DTZ | 1992-11-30 | 165 |
| K854963 | S80 IMPLANTABLE CARDIAC PACING LEAD | DTB | 1986-06-24 | 195 |
| K852641 | ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER | DXY | 1986-01-14 | 208 |
| K851365 | SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM | DXY | 1985-12-03 | 242 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sorin Biomedica, Fiat, USA, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Sorin Biomedica, Fiat, USA, Inc. (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sorin Group Italia S.R.L. (61 510(k)s)
- Sorin Group Deutschland GmbH (20 510(k)s)
- Sorin Biomedical, Inc. (15 510(k)s)
- Sorin Group USA, Inc. (2 510(k)s)
- Sorin Biomedica Cardio S.R.L. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sorin Biomedica, Fiat, USA, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Sorin Biomedica, Fiat, USA, Inc.” (first 1980, latest 1994), across 16 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sorin Biomedica, Fiat, USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sorin Biomedica, Fiat, USA, Inc. is 116 days.
Which FDA product codes appear under Sorin Biomedica, Fiat, USA, Inc.?
The most frequent FDA product codes under this applicant name are CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 2); DTZ (Oxygenator, Cardiopulmonary Bypass, 2); DXY (Implantable Pacemaker Pulse-Generator, 2).
Next steps
- See all 20 Sorin Biomedica, Fiat, USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDZ, Sorin Biomedica, Fiat, USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.